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Clinical Trials/NCT05530525
NCT05530525
Completed
N/A

Psychometric Evaluation of Commonly Used Measures in Patients With Stroke Using Medical Record Review

Buddhist Tzu Chi General Hospital1 site in 1 country50 target enrollmentApril 1, 2022
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Buddhist Tzu Chi General Hospital
Enrollment
50
Locations
1
Primary Endpoint
The National Institutes of Health Stroke Scale
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

Purposes: The aim of this study is to examine the psychometric properties (e.g. test-retest reliability, random measurement error, practice effect, and responsiveness) of the commonly used measures in patients with stroke using medical record review.

The investigators anticipate reviewing 1000 stroke patients' medical record from a medical center in Taiwan. The medical record will be reviewed by an experienced and well-trained occupational therapist.

Detailed Description

The investigators anticipate reviewing 1000 stroke patients' medical record (from 2018/6/1 to 2021/6/30) from a medical center in Taiwan. The medical record will be reviewed by an experienced and well-trained occupational therapist. The study was approved by the local institutional review board. Because the targeted populations for examining the test-retest reliability and responsiveness were different, the inclusion criteria were listed separately below. Test-retest reliability Chronic stroke patients' data was reviewed to examine the test-retest reliability. The participants met the following criteria: (1) diagnosis of cerebral hemorrhage or cerebral infarction, (2) age ≥ 20 years, and (3) stroke onset ≥ 6 months (first and recurrent stroke included). Responsiveness Subacute stroke patients' data was reviewed to examine the responsiveness. The participants met the following criteria: (1) diagnosis of cerebral hemorrhage or cerebral infarction, (2) age ≥ 20 years, and (3) stroke onset \< 3 months (first and recurrent stroke included).

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
December 31, 2023
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Buddhist Tzu Chi General Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

The National Institutes of Health Stroke Scale

Time Frame: The repeated assessments were performed at an one-month interval.

The National Institutes of Health Stroke Scale comprises 11 items and was used to monitor the severity in the patients with stroke. The total score ranges from 0 to 42, with a higher score indicating greater severity. A National Institutes of Health Stroke Scale score of 1-5 indicates mild severity; 6-14, mild to moderate severity; 15-24, severe severity; and equal to or greater than 25, very severe severity.

The computerized adaptive testing system of the functional assessment of stroke

Time Frame: The repeated assessments were performed at an one-month interval.

The Computerized Adaptive Testing system of the Functional Assessment of Stroke comprises 58 items. The items were selected from four well-known physical function measures for patients with stroke: 26 items from the Fugl-Meyer Assessment-Upper limb, 11 items from the Fugl-Meyer Assessment-Lower limb, 12 items from the Postural Assessment Scale for Stroke Patients, and 9 items from the Barthel Index. These items evaluate motor control, postural control, and activity of daily living functions in patients with stroke. Results are automatically reported as Rasch scores (i.e., the minimum and maximum values are negative and positive infinity, respectively). A higher score indicates greater physical functions.

The Barthel Index

Time Frame: The repeated assessments were performed at an one-month interval.

The Barthel Index has 10 items, and the total score ranges from 0 to 100. Higher score indicates less disability on activity of daily living functions.

Study Sites (1)

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